BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH

    MDR report key: 12624792 · Received October 13, 2021

    Report

    Report Number
    1222780-2021-00298
    Event Type
    Death
    Date Received
    October 13, 2021
    Date of Event
    September 29, 2021
    Report Date
    October 13, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT RECEIVED A MYOSURE PROCEDURE TO REMOVE A FIBROID AT THE INTERNAL OS OF THE PATIENT¿S CERVIX. A MYOSURE REACH WAS USED IN THE PROCEDURE AND THERE WAS NO SUSPICION OF PERFORATION AND THE FLUID DEFICIT WAS AROUND 1000 ML. THE PROCEDURE WAS COMPLETED WITH AN AQUILEX SYSTEM. THE PATIENT WAS SENT TO THE PACU AFTER THE PROCEDURE WITHOUT COMPLICATIONS AND WAS SENT HOME. THE PHYSICIAN FOLLOWED WITH THE PATIENT THE SAME EVENING AND THE PATIENT REPORTED STOMACH PAIN RELATED TO FOOD. THE PHYSICIAN WAS INFORMED THAT THE PATIENT PASSED AWAY ON (B)(6) OF A HEART ATTACK. THE PHYSICIAN CALLED TO REPORT THERE WAS NO REASON TO SUSPECT THAT THE PATIENT¿S DEATH WAS RELATED TO THE MYOSURE PROCEDURE AND THE PATHOLOGY REPORT CAME BACK AND CONFIRMED THAT THE TISSUE REMOVED WAS ENDOCERVICAL CURETTINGS AND ENDOCERVICAL POLYP AND FIBROID. THE MEDICAL EXAM CONFIRMED CAUSE OF DEATH AS HEART ATTACK PER DR. (B)(6). NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526010 MYOSURE REACH HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 10-401FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AQUILEX